FDA Inspection
Genesys Health System IRBGenesys Health System IRB – FDA Inspection, Feb 23, 2011
Record Details
This FDA Inspection record concerns Genesys Health System IRB, with an inspection on February 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Genesys Health System IRB
- Inspection Date
- February 23, 2011
- Product Type
- Devices
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ID · dc805ffc-a8d1-4390-964c-a638b84cc421
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 712644
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
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Other FDA inspections of Genesys Health System IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Genesys Health System IRB
- FDA Inspection 1068230 - 2018-09-20
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